Biological variation of Lp(a) and its application in a lipid clinic
Research type
Research Study
Full title
Determination of biological variation of Lipoprotein (a) and its application in routine clinical care in a lipid clinic
IRAS ID
319104
Contact name
Kofi Antwi
Contact email
Sponsor organisation
University Hospitals Bristol and Weston NHS Trust
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Elevated lipoprotein (a) [Lp(a)] leads to increased incidence of coronary heart disease (CHD), stroke and aortic valve stenosis. Data from a biological variation study to estimate a reference change value (RCV), the minimum value which indicates a significant change, for Lp(a) has not been directly applied in real life settings. The study will help determine whether interventions which has been noted in clinical trials to lower Lp(a) concentration exceeds the RCV of Lp(a). The study will be conducted from the Department of Clinical Biochemistry at Bristol Royal Infirmary and is comprised of three primary stages.
Stage one involves the use of the basic framework of method verification for the evaluation of the quantitative immunoturbidimetric Lp(a) assay used in the study. Pooled plasma samples with known Lp(a) levels, will be analysed over daily and weekly intervals to determine stability, intra- and inter-assay precision.
Stage two involves healthy participants, recruited from staff aged between 18 and 65 years. A baseline blood sample will be first taken, with further samples taken over six weeks. These samples will be processed, and the plasma will be separated and analysed for Lp(a) levels. The results will be used in the calculation of the RCV.
Stage three involves blood samples taken from patients at the lipid clinic under the care of the BRI Lipid Clinic commenced on a PCSK9 inhibitor or Inclisiran. This will be taken three months after the patient has begun their treatment to be analysed for Lp(a). All blood samples will be taken as part of routine care, and the Lp(a) analysis conducted on the samples taken at the 3-month mark is the only procedure being conducted above routine care for these patients. Any observed changes in Lp(a) will be compared to the estimated RCV from stage 2.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
23/EM/0135
Date of REC Opinion
15 Aug 2023
REC opinion
Further Information Favourable Opinion